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FDA Approval Activities for this Drug…
Epipen 0.3 mg Epinephrine auto-injector Meridian Technologies NDA 19-430/S12 Septocaine (articaine & epinephrine) Injection, Deproco, NDA 20-971 Twinject Auto-Injector (epinephrine) injection, Hollister-Stier , NDA 20-800 ARTICAINE HYDROCHLORIDE; EPINEPHRINE Injection 4%;EQ 0.01MG BASE/ML SEPTOCAINE DEPROCO 071165 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Injection 0.25%;0.005MG/ML BUPIVACAINE HCL AND EPINEPHRINE Abbott 071166 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Injection 0.25%;0.005MG/ML BUPIVACAINE HCL AND EPINEPHRINE Abbott 071167 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Injection 0.25%;0.005MG/ML BUPIVACAINE HCL AND EPINEPHRINE Abbott 071168 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Injection 0.5%;0.005MG/ML BUPIVACAINE HCL AND EPINEPHRINE Abbott 071169 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Injection 0.5%;0.005MG/ML BUPIVACAINE HCL AND EPINEPHRINE Abbott 071170 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Injection 0.5%;0.005MG/ML BUPIVACAINE HCL AND EPINEPHRINE Abbott 071171 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Injection 0.75%;0.005MG/ML BUPIVACAINE HCL AND EPINEPHRINE Abbott 016964 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.25%;0.0091MG/ML MARCAINE HCL W/ EPINEPHRINE Abbott 016964 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.25%;0.0091MG/ML MARCAINE HCL W/ EPINEPHRINE PRESERVATIVE FREE Abbott 016964 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.5%;0.0091MG/ML MARCAINE HCL W/ EPINEPHRINE PRESERVATIVE FREE Abbott 016964 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.5%;0.0091MG/ML MARCAINE HCL W/ EPINEPHRINE Abbott 016964 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.75%;0.0091MG/ML MARCAINE HCL W/ EPINEPHRINE PRESERVATIVE FREE Abbott 070966 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.25%;0.0091MG/ML SENSORCAINE ASTRAZENECA 070967 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.25%;0.0091MG/ML SENSORCAINE ASTRAZENECA 070968 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.5%;0.0091MG/ML SENSORCAINE ASTRAZENECA 018304 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.5%;0.0091MG/ML SENSORCAINE ASTRAZENECA 018304 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.75%;0.0091MG/ML SENSORCAINE ASTRAZENECA 020800 EPINEPHRINE Im-Sc 0.3MG /DELIVERY TWINJECT HOLLISTER STIER 019430 EPINEPHRINE Intramuscular 0.15MG/DELIVERY EPIPEN JR. MERIDIAN MEDCL TECHN 019430 EPINEPHRINE Intramuscular 0.3MG/DELIVERY EPIPEN MERIDIAN MEDCL TECHN 017751 EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;1% DURANEST ASTRAZENECA 088390 EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG BASE/ML;2% LIGNOSPAN STANDARD DEPROCO 088389 EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE Injection 0.02MG BASE/ML;2% LIGNOSPAN FORTE DEPROCO 021383 EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE Injection 0.005MG/ML;4% CITANEST FORTE DENTSPLY 089635 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;0.5% LIDOCAINE HCL AND EPINEPHRINE Abbott 089649 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;1% LIDOCAINE HCL AND EPINEPHRINE Abbott 089650 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;1.5% LIDOCAINE HCL AND EPINEPHRINE Abbott 088571 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;1.5% LIDOCAINE HCL AND EPINEPHRINE Abbott 089645 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;1.5% LIDOCAINE HCL AND EPINEPHRINE Abbott 089651 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;2% LIDOCAINE HCL AND EPINEPHRINE Abbott 089644 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;1% LIDOCAINE HCL AND EPINEPHRINE Abbott 089646 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;2% LIDOCAINE HCL AND EPINEPHRINE Abbott 006488 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;0.5% XYLOCAINE W/ EPINEPHRINE ASTRAZENECA 006488 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;1% XYLOCAINE W/ EPINEPHRINE ASTRAZENECA 006488 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;1.5% XYLOCAINE W/ EPINEPHRINE ASTRAZENECA 006488 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;2% XYLOCAINE W/ EPINEPHRINE ASTRAZENECA 006488 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;1% XYLOCAINE W/ EPINEPHRINE ASTRAZENECA 083389 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;1% LIDOCAINE HCL W/ EPINEPHRINE DELL 083390 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;2% LIDOCAINE HCL W/ EPINEPHRINE DELL 021381 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;2% XYLOCAINE W/ EPINEPHRINE DENTSPLY 021381 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.02MG/ML;2% XYLOCAINE W/ EPINEPHRINE DENTSPLY 040057 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;2% LIDOCAINE HCL AND EPINEPHRINE EASTMAN KODAK 040057 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.02MG/ML;2% LIDOCAINE HCL AND EPINEPHRINE EASTMAN KODAK 080504 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;2% LIDOCAINE HCL AND EPINEPHRINE GRAHAM CHEM 080504 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.02MG/ML;2% LIDOCAINE HCL AND EPINEPHRINE GRAHAM CHEM 084729 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;2% LIDOCATON PHARMATON 084048 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;2% OCTOCAINE SEPTODONT 084048 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.02MG/ML;2% OCTOCAINE SEPTODONT 020530 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Solution; Iontophoresis 2% IONTOCAINE IOMED 007513 NOREPINEPHRINE BITARTRATE Injection 1MG BASE/ML LEVOPHED Abbott 040455 NOREPINEPHRINE BITARTRATE Injection 1MG BASE/ML NOREPINEPHRINE BITARTRATE Gensia Sicor Epipen & Epipen Jr. (Epinephrine) Injection, Meridian Technologies | Twinject Auto-Injector (epinephrine) injection, Hollister-Stier Labs, Manufacturing Change or Addition | LidoSite Patch, Vyteris, Inc., Labeling Revision | Twinject Auto-Injector (epinephrine) injection, Hollister-Stier Labs, Manufacturing Change or Addition | Twinject Auto-Injector (epinephrine), Hollister-Stier Labs, Labeling Revision | Marcaine (Bupivacaine Hydrochloride) Injection and Marcaine w/Epinephrine, Hospira, Labeling Revision | Bupivacaine Hydrochloride & Epinephrine Injection, Septodont Inc., Approval | Septocaine (Articaine Hydrochloride w/Epinephrine Injection), Deproco Inc., Labeling Revision | Twinject Auto-Injector (epinephrine) Injection, Verus Pharma, Control Supp. | Lidocaine Hydrochloride and Epinephrine Injection, Hospira, Inc., Approval | EpiPen and Epi E Z Pen Jr (epinephrine) Intramuscular Injection, Meridian Medical Technologies Inc., Labeling Revision
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